Recalls / Class II
Class IID-1030-2016
Product
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
- Affected lot / code info
- BZP0093A, BZP0094A, BZP0095A, BZP0096A, BZP0097A, Exp 02/2017
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Nostrum Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 705 E Mulberry St, Bryan, Ohio 43506-1432
Distribution
- Quantity
- 2839 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-23
- FDA classified
- 2016-06-14
- Posted by FDA
- 2016-06-22
- Terminated
- 2017-04-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1030-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.